Device Classification Name |
mesh, surgical
|
510(k) Number |
K192615 |
Device Name |
Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG) |
Applicant |
Synovis Life Technologies, Inc. (Baxter International Inc.) |
2575 University Ave. W |
St. Paul,
MN
55114
|
|
Applicant Contact |
Megan Sajjad |
Correspondent |
Synovis Life Technologies, Inc. (Baxter International Inc.) |
2575 University Ave. W |
St. Paul,
MN
55114
|
|
Correspondent Contact |
Megan Sajjad |
Regulation Number | 878.3300
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/23/2019 |
Decision Date | 12/17/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|